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Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075806

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NDA 075806 describes NIZATIDINE, which is a drug marketed by Mylan Pharms Inc, Dr Reddys Labs Ltd, Watson Labs, Glenmark Generics, Ani Pharms Inc, Amneal Pharms, Sandoz, and Apotex Inc, and is included in ten NDAs. It is available from eighteen suppliers. Additional details are available on the NIZATIDINE profile page.

The generic ingredient in NIZATIDINE is nizatidine. There are seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the nizatidine profile page.

Summary for NDA: 075806

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075806

Suppliers and Packaging for NDA: 075806

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIZATIDINE
nizatidine
CAPSULE;ORAL 075806 ANDA Mylan Pharmaceuticals Inc. 0378-5150 0378-5150-91 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-5150-91)
NIZATIDINE
nizatidine
CAPSULE;ORAL 075806 ANDA Mylan Pharmaceuticals Inc. 0378-5300 0378-5300-93 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-5300-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jul 5, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Jul 5, 2002TE:ABRLD:No


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